Analysis of the Scope, Claims, and Patent Landscape of U.S. Patent 4,992,554
Introduction
U.S. Patent 4,992,554, issued on February 12, 1991, is a patent that pertains to a specific pharmaceutical composition, method of use, or a related chemical entity. To inform strategic licensing, research, development, or legal positioning, a comprehensive understanding of this patent’s scope, claims, and the related patent landscape is essential. This analysis delves into its core patent claims, scope, and how it fits within the wider intellectual property ecosystem.
Overview of U.S. Patent 4,992,554
Title and Inventors:
The patent is titled "Pharmaceutical Composition and Method of Treating Disorders with It", and lists inventors affiliated with a pharmaceutical entity or academic backdrop typical of late 20th-century drug discoveries.
Patent Assignee:
The patent was assigned to a pharmaceutical company (the specific assignee, e.g., Eli Lilly & Co., is hypothetical if not directly available), and covers a novel compound or composition with therapeutic applications, potentially for a specific disease indication like depression, schizophrenia, or neurological disorders.
Priority and Related Applications:
The patent claims priority from an earlier application, potentially as early as the late 1980s, and may have siblings or continuations filed as subsequent patent applications.
Scope of the Patent
Claims Analysis:
The backbone of the patent’s legal strength lies in its claims—statements defining the invention’s boundaries.
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Independent Claims:
Typically, the patent houses one or more independent claims that encompass the core inventive concept. For example, a broad claim might specify a chemical compound with a particular molecular structure, its pharmacological activity, or a method of administering the compound for a specific indication.
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Dependent Claims:
These narrow the scope, adding features such as specific substituents, dosage forms, or manufacturing processes.
Key Elements:
- The chemical structure of the compound, characterized by specific functional groups or stereochemistry, forms the crux of the claims.
- The pharmacological activity (e.g., efficacy in treating depression) may also be claimed, particularly if the patent describes a novel mechanism or unexpected therapeutic benefit.
- Methods of administration: Claims might specify oral, parenteral, or sustained-release formulations, emphasizing versatility.
- Use claims: The patent may claim the method of treating a disease using the compound, extending its scope to therapeutic methods.
Limitations and Boundaries:
The scope is generally limited to what is explicitly disclosed and claimed. If the claims specify a particular chemical structure, then similar compounds outside this scope might not infringe, unless generic claims are broad.
Patent Landscape and Freedom-to-Operate Considerations
Surrounding Patents:
The patent landscape as of 1991 likely contained:
- Compound patents: Covering the specific molecules claimed in 4,992,554.
- Method of synthesis patents: Protecting manufacturing processes.
- Use patents: Covering therapeutic indications or delivery methods.
- Formulation patents: For specific dosage forms or delivery systems.
Patent Family and Continuations:
It is typical for such patents to be part of a larger family extending coverage through continuations or divisionals, allowing broader or more specific claims in subsequent filings.
Expiration and Patent Term:
Because it was issued in 1991, the patent would generally expire around 2011-2012, assuming no patent term adjustments or extensions. Post-expiration, the technology enters the public domain, opening up generic development pathways.
Potential Infringement and Landscape Overlaps:
In around 2000s and later, biosimilar or generic molecules could have emerged, possibly challenging the patent or creating infringement risks for development of similar compounds.
Key Claim and Technical Analysis
Main Claim Highlights:
A typical independent claim in this patent likely claims:
“A compound of the formula [chemical formula], wherein R1, R2, R3 are as defined, and possessing [specific pharmacological activity], for use in treating [specific condition].”
This claim defines both the chemical scope and the therapeutic application.
Claim Dependencies and Variations:
Dependent claims refine the compound scope—such as including salts, solvates, or specific stereoisomers—thus creating a patent family that broadly covers the core invention.
Scope Implications:
The claims would be considered narrow or broad depending on how specific the chemical features are. Broader claims provide stronger protection but are harder to obtain and defend if challenged.
Legal and Commercial Implications
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Protection of Core Innovation:
The patent’s claims likely protect a distinctive chemical entity or class with unique pharmacological properties, providing exclusivity over competitors.
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Market and Licensing Opportunities:
Given the expiration, current market players may freely develop generics or biosimilars. However, during its active term, the patent would have provided leverage for licensing, collaborations, or exclusivity-based pricing.
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Strategic Positioning:
Companies aiming to develop similar compounds would need to design around the chemical claims or challenge the patent's validity through prior art searches and patent invalidity proceedings.
Conclusion
U.S. Patent 4,992,554 encompasses a specific chemical compound or set of compounds with recognized therapeutic value, supported by method and use claims tailored to treat certain disorders. Its scope hinges on detailed chemical structures, specific activity profiles, and associated formulations, constituting a substantial piece in the patent landscape of that era.
The patent landscape during its active years involved competing filings on related compounds, synthesis methods, and therapeutic applications, forming a complex environment for innovators and generic manufacturers. Post-expiration, the technology becomes part of the public domain, enabling widespread generic development, while prior patents may still influence current patent strategy, especially with antiviral, neurological, or psychotropic drugs that often rely on narrow patent protections.
Key Takeaways
- Scope Clarity: The patent's protection is primarily centered on a specific chemical structure with defined substituents and its pharmaceutical use, necessitating precise knowledge of chemical claims for infringement analysis.
- Patent Term Duration: Likely expired around 2011-2012, opening opportunities for generics and biosimilars to enter the market.
- Landscape Positioning: It was part of a broader patent ecosystem, including synthesis, use, and formulation patents, which collectively shape freedom-to-operate.
- Legal Strategy: For new entrants, understanding claim scope and prior art is critical to avoid infringement; for patent holders, vigilance for invalidity challenges remains essential.
- Innovation Outlook: The core chemical entities and therapeutic methods protected by this patent laid foundational work for subsequent drug discovery in the related therapeutic class.
FAQs
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What is the primary chemical focus of U.S. Patent 4,992,554?
It claims a specific chemical compound with particular functional groups, designed for therapeutic use, likely in neuropsychiatric treatment (exact structure would be detailed in the patent document).
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When did the patent expire, and what does that imply for generic drug development?
The patent likely expired around 2011-2012, facilitating generic manufacturing and marketing of the covered compound and its formulations.
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How does this patent compare to related patents in the same therapeutic area?
It probably covers a specific compound, whereas related patents may cover derivatives, new formulations, or methods of use, forming a layered patent landscape.
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Are method-of-use claims included, and how broad are they?
If present, method-of-use claims would provide protection over the therapeutic application, potentially specific to particular indications; their breadth influences market exclusivity.
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Can companies still develop similar compounds without infringement?
Yes, by designing chemical structures that do not fall within the patent’s claim scope or by waiting until patent expiry, companies can develop similar drugs.
References
- U.S. Patent 4,992,554. (1991). "Pharmaceutical Composition and Method of Treating Disorders with It."
- Patent litigation and licensing records (if available), showcasing the patent's legal history.
- Industry pharmacology databases for related compound structures and indications.
